Phase III microbicide trial methodology

In preparation for effectiveness trials of candidate vaginal microbicides, scientists are debating trial design and implementation challenges, including choice of control arm(s), product-sharing across arms, and visit schedules. This study involved a survey of South African women participating in an expanded safety trial of the candidate microbicide Carraguard gel. The first 100 consenting women who attended the study clinics in Ga-Rankuwa and Gugulethu (total N = 200) were interviewed; all women had been using a study gel for at least 6 months at the time of the interview. The study found that many participants thought that including a condoms-only arm would result in increased product-sharing, male partner resistance to trial participation and decreased enrollment; no clear patterns emerged regarding the potential effect on condom use and cohort retention. The majority of women preferred a monthly visit schedule, would be willing to use a product for 2 years, and thought that their product use would not decrease over time. Thus flexibility in trial design and implementation strategies is needed until evidence-based decisions can be made. When including a condoms-only arm, extra efforts should be made to explain the importance of all study arms to potential participants and to measure adherence and product-sharing

Condom · Environmental health · Family medicine · Microbicide · Microbicides for sexually transmitted diseases · Population · Randomized controlled trial · Schedule · Vaginal microbicide · Adolescent Sexual and Reproductive Health · HIV/AIDS Research and Interventions · Medicine · Reproductive tract infections research · Surgery

• Sharing of Investigational Drug Among Participants in the Voice Trial

  Open Access•Jeeva Moodley, Sarita Naidoo et al.•AIDS and Behavior•2016

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